MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS

Model Number 8606500

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that a ventilator failure occurred during a case.No injury reported.

Manufacturer Narrative

The log file was analyzed for the reported date of event, (b)(6) 2021 whereby three motor encoder check errors were found.Thereupon, according to the device safety concept, the system forced a shutdown of the automatic ventilation and posted the corresponding "ventilator failure" alarm.Manual ventilation and monitoring functions remain available in this case.After the event the motor was replaced and was made available for further investigation at manufacturer¿s site.An evaluation of the motor in the laboratory revealed that in several positions the motor did not provide mechanic power due to a mechanically abraded collector disc.In this case the electrical contact between the collector disc and the carbon brushes is partly disrupted.The consequence are fluctuations in the rotating speed so that the measured ventilator piston position does not match with the one calculated by the system's software.To prevent from potentially hazardous output and/or from damages to the ventilator unit the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Finally, it can be concluded that the device has responded to a detected malfunction of a single component as specified.The repair exchange will fully solve the device problem.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that a ventilator failure occurred during a case.No injury reported.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 12237648
• MDR Text Key: 265867126
• Report Number: 9611500-2021-00321
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8606500
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1